Neural Noise

LivaNova neuromodulation

2 min read

  • LivaNova is a leading neuromodulation company focused on vagus nerve stimulation (VNS) and cardiac rhythm management.1
  • Their VNS devices are approved for epilepsy and depression, representing an established neuromodulation commercial platform.1 1

Weekly enrichment (2026-07-20)

  • LivaNova PLC (Nasdaq: LIVN) markets VNS Therapy, approved as adjunctive treatment for drug-resistant epilepsy in adults and children as young as 4 with partial-onset seizures, via an outpatient implant that does not require penetrating the skull.2 3
  • Its CORE-VNS real-world study, completed in 2025, enrolled more than 800 people with drug-resistant epilepsy across 61 worldwide sites; the final 36-month data further validated effectiveness for severe focal seizures in both children and adults.3
  • Drug-resistant epilepsy — the target indication for VNS Therapy — affects roughly one in three people with epilepsy.3
  • The RECOVER trial (NCT03887715), industry-sponsored and started in September 2019, tests VNS as adjunctive therapy for treatment-resistant depression against a no-stimulation control, with the primary endpoint measured 12 months after randomization and primary completion estimated for February 2028.4
  • In RECOVER’s design the control arm is implanted but left inactive for the first 12 months and then crossed over to open-label stimulation; the registry lists an estimated enrollment of 6,800 participants.4
  • RECOVER’s preliminary results did not meet the primary endpoint (difference in MADRS response rate between active and sham) because of an unexpectedly strong sham response, but active VNS produced statistically significant, clinically meaningful benefits on specific secondary endpoints.5
  • Beyond VNS, LivaNova is expanding into obstructive sleep apnea with the aura6000 System, which uses proximal hypoglossal nerve stimulation (p-HGNS) delivered through six electrodes placed on the proximal trunk of the hypoglossal nerve for customized titration.6
  • OSPREY randomized controlled trial 12-month top-line data (announced May 2025) reported a treatment-arm responder rate of 65% (defined as ≥50% reduction in apnea-hypopnea index and AHI below 20), with no serious device- or procedure-related adverse events; LivaNova completed a premarket approval submission to FDA based on meeting the six-month endpoints.6

Footnotes

  1. https://neuralimplantpodcast.com/livanova ↩ ↩2 ↩3

  2. https://www.livanova.com/epilepsy-vnstherapy/en-us ↩

  3. https://investor.livanova.com/news-releases/news-release-details/core-vns-study-further-validates-effectiveness-livanovas-vns ↩ ↩2 ↩3

  4. https://clinicaltrials.gov/study/NCT03887715 ↩ ↩2

  5. https://med.uth.edu/psychiatry/2024/06/17/preliminary-findings-from-livanovas-recover-clinical-study-on-vns-therapy-for-treatment-resistant-depression/ ↩

  6. https://investor.livanova.com/news-releases/news-release-details/livanova-announces-12-month-data-osprey-clinical-study-moderate ↩ ↩2

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